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May 15, 2017

AstraZeneca’s Imfinzi meets primary endpoint in Phase III trial for stage III NSCLC

AstraZeneca and its biologics research and development arm MedImmune have reported positive results from the Phase III PACIFIC clinical trial of Imfinzi (durvalumab) to treat patients with locally advanced, unresectable (stage III) non-small-cell lung cancer (NSCLC).

AstraZeneca and its biologics research and development arm MedImmune have reported positive results from the Phase III PACIFIC clinical trial of Imfinzi (durvalumab) to treat patients with locally advanced, unresectable (stage III) non-small-cell lung cancer (NSCLC).

Imfinziis a human monoclonal antibody designed to block PD-L1 interaction with PD-1 and CD80 present on T-cells.

The results from the interim analysis showed that the primary endpoint of statistically significant and clinically meaningful progression-free survival (PFA) has been met.

The randomised, double-blinded, placebo-controlled, multicentre Phase III trial evaluated Imfinzi as a sequential treatment in patients whose disease had not progressed after receiving standard platinum-based chemotherapy concurrent with radiation therapy.

The PACIFIC trial is currently being conducted at 235 centres across 26 countries such as the US, Canada, Europe, South and Central America, Japan, Korea, Taiwan, South Africa and Australia, and will also assess overall survival as the other primary endpoint, and objective response rate and duration of response as secondary endpoints.

"These are highly encouraging results for patients with locally advanced lung cancer for whom surgery is not an option."

AstraZeneca chief medical officer and global medicines development executive vice-president Sean Bohen said: “These are highly encouraging results for patients with locally advanced lung cancer for whom surgery is not an option.

“We look forward to working with regulatory authorities around the world to bring Imfinzi to lung cancer patients as soon as possible.”

Imfinzi is being further studied as a monotherapy in Phase III trials for various NSCLC stages, small-cell lung cancer (SCLC), urothelial bladder cancer, and head and neck squamous cell carcinoma (HNSCC).

It is also being investigated as a combination therapy with tremelimumab in urothelial bladder cancer, NSCLC, SCLC and HNSCC, as well as in Phase I/II trials for gastric and pancreatic cancer, hepatocellular carcinoma and haematological malignancies.


Image: AstraZeneca chief medical officer and Global Medicines Development executive vice-president Sean Bohen. Photo: © AstraZeneca.

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